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Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Primary Purpose

Pulmonary Non-tuberculous Mycobacterial Lung Disease

Status

Withdrawn

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Amikacin

About this trial

This is an interventional treatment trial for Pulmonary Non-tuberculous Mycobacterial Lung Disease focused on measuring Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria.
MAC lung disease with persistent sputum culture positive after 6 months of standard treatment
M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment
New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment

Exclusion Criteria:

Subjects with negative sputum culture before starting of this study
Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening.
Positive in HIV test.
Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL)
Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1.5 times of upper normal limits)
Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening.
Subjects with history of allergy to amikacin.
Subjects with pregnant state or women of childbearing age with no appropriate contraception.

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amikacin for inhalation

Arm Description

Drug: Amikacin Amikacin is provided for inhalation via nebulization. 500 mg of amikacin is administered once daily using the Pari-Boy N/Long Life Nebulizer. Administration time is approximately 20 minutes. Amikacin will be administered for 2 years.

Outcomes

Primary Outcome Measures

Culture conversion rates at 6 months

Secondary Outcome Measures

Culture conversion rates at 12 months

Culture conversion rates at 24 months

Assessment of abnormal lab values

Assessment of adverse events related to the study drug or study device

Full Information

NCT ID

NCT01528930

First Posted

January 30, 2012

Last Updated

December 14, 2012

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01528930

Brief Title

Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

Official Title

Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Although this study was approved at the Institutional Review Board, Korea Food & Drug Administration (KFDA) did not approve this study due to safety concern.

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may require multiple drugs. Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin treatment is limited by its systemic route of administration and a lot of adverse events. Amikacin inhalation treatment could overcome these limitations and also could be effective for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The purpose of this study is to determine whether amikacin inhalation treatment is effective in patients with MAC infection who experienced treatment failure after standard treatment for more than 6 months or with M. abscessus infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Non-tuberculous Mycobacterial Lung Disease

Keywords

Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amikacin for inhalation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Amikacin

Intervention Description

500 mg, once daily for 2 years

Primary Outcome Measure Information:

Title

Culture conversion rates at 6 months

Time Frame

6 months after starting treatment

Secondary Outcome Measure Information:

Title

Culture conversion rates at 12 months

Time Frame

12 months after starting treatment

Title

Culture conversion rates at 24 months

Time Frame

24 months after starting treatment

Title

Assessment of abnormal lab values

Time Frame

For 24 months of treatment

Title

Assessment of adverse events related to the study drug or study device

Time Frame

For 24 months of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria. MAC lung disease with persistent sputum culture positive after 6 months of standard treatment M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment Exclusion Criteria: Subjects with negative sputum culture before starting of this study Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening. Positive in HIV test. Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL) Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1.5 times of upper normal limits) Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening. Subjects with history of allergy to amikacin. Subjects with pregnant state or women of childbearing age with no appropriate contraception.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won-Jung Koh

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

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Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

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